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Completed

NCT Number: NCT03392727

Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program

This study will evaluate baby box ownership and safe sleep practices (sleep location, sleep position, use of bedding) among families provided a free baby box and standardized safe sleep education compared to families provided a safe sleep pamphlet and information on how to obtain a free box in the community.

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Key information

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3E 3P5, Canada

About this study

The proposed study is a randomized controlled trial with two arms: the intervention group (n=110) will be provided a baby box and standardized face to face education regarding the box and its contents, safe sleep, and infant health promotion; the control group (n=110) will be provided information on how to obtain the same baby box at a community site in Winnipeg, and will receive a safe sleep pamphlet, baby box pamphlet and a guide to online resources for prenatal ad infant health promotion. An additional comparison group will be parents who already have a baby box at the time of recruitment. This group will also receive the safe sleep pamphlet. Families will be interviewed at recruitment and 2-4 months of age to measure box ownership and self-reported safe sleep and infant health promotion practices. Administrative data will be used to evaluate the impact on infant immunizations and hospitalizations in the first year of life, and to evaluate the impacts of prenatal care visits and neonatal length of stay on the outcomes.

Families will be asked to participate in a face to face interview at baseline (enrolment) and one follow-up interview coordinated with a scheduled routine healthcare visit for the infant at 2 months of age and conducted face to face or by telephone, according to family preference.

PHIN will be requested for both mother and infant in order to explore the relationship between adequacy of prenatal care and the study outcomes, and to evaluate the impact on infant immunizations and hospitalizations in the first year of life. Postal code will be requested to analyze differences related to place of residence and neighbourhood income quintile.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mothers who are 32 weeks or more gestation
  • Infants less than 3 months of age (or post-conceptional age 44 weeks)
  • Able to consent freely and complete face to face and/or telephone interviews in English
  • Will be residing in Winnipeg until the infant is 2-4 months of age or able to complete a telephone interview at 2-4 months of age

Exclusion criteria

  • Parent/guardian/client less than 18 years of age (unless emancipated minor)
  • Parents who cannot consent due to intellectual capacity, medical condition, etc.
  • Infant is discharged from hospital in the care of Child and Family Services or a birth alert is in place

Treatment and study plan

Study Box

Device

Baby box (bassinet) with infant items

Community Box

Device

Baby box (bassinet)

Education Session

Behavioral

Face to face education and baby box orientation session

Online education

Behavioral

Online baby box education

Primary outcomes

  1. Box ownership

    Time frame: 2 months

    Parents with a baby box

  2. Usual sleep location

    Time frame: 2 months

    crib, cradle, bassinet, box, other

  3. Baby box use for sleep

    Time frame: 2 months

    always/sometimes/never/not applicable

  4. Usual sleep position

    Time frame: 2 months

    supine, other

  5. Usual infant clothing for sleep

    Time frame: 2 months

    sleeper, sack, swaddled

  6. Usual bedding

    Time frame: 2 months

    none, tucked blanket, other

Secondary outcomes

  1. Safe sleep knowledge

    Time frame: 2 months

    safe sleep location, position, infant clothing, bedding (1 point each)

  2. Current infant feeding

    Time frame: 2 months

    breastfeeding, formula feeding, both

  3. Household smoking

    Time frame: 2 months

    total number of cigarettes smoked per day in the household

  4. Vitamin D

    Time frame: 2 months

    Infant provided daily dose of Vitamin D (always/sometimes/never)

  5. Immunizations

    Time frame: 12 months

    Number of infant immunizations in the first year of life

  6. Prenatal visits

    Time frame: 9 months

    Number of prenatal visits

  7. Infant hospitalizations

    Time frame: 12 months

    Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)

Other outcomes

  1. Adverse events

    Time frame: 2 months

    Parent-reported adverse events and concerns regarding the baby box

  2. Parent feedback

    Time frame: 2 months

    Parent-reported opinions and preferences (likes/dislikes) regarding the baby box and the distribution process

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Paediatric Society
  • Manitoba Health, Seniors and Active Living

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2018
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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